MAUDE Adverse Event Report: CODMAN CODMAN LUMBAR EXTERNAL DRAINAGE CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Lot Number 3554939

Device Problem Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2020

Event Type  Injury  

Event Description

Anesthesia placed spinal drain in sitting position with 10 cm of catheter placed without issue and draining csf- 3 cc of csf aspirated and attached to spinal drain.Placed lines and checked spinal drain.Unable to drain csf- turned on side and checked- not functioning.Decision made to removed spinal drain.Catheter sheered off at approx 5 cm.Fda safety report id # (b)(4).

• Brand Name: CODMAN LUMBAR EXTERNAL DRAINAGE CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN
• MDR Report Key: 10919161
• MDR Text Key: 218978265
• Report Number: MW5098131
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Lot Number: 3554939
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR